Trace Elements Concentration in Dialysis

Dialysis Clinical Trial

— EMTDialyse  

Official title:

Trace Elements Concentration in Dialysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05031013
• Other study ID #: 021ACR-EMTDialyse
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: February 2022

Study information

• Verified date: August 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Aymeric Couturier, MD
• Phone: +33171167685
• Email: aymeric.couturier[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In hemodialysis population the study team finds high concentrations of toxic trace elements (2 times higher than the general population for cadmium 4 to 13 times for lead). Several recent studies suggest a role of chronic exposure to cadmium in the loss of residual renal function, osteoporosis, graft failure, arteriosclerosis, as well as in excess cardiovascular mortality. Moreover, in hemodialysis population, a deficit of certain essential trace elements (manganese, selenium, zinc) is observed. For example, in the population undergoing chronic hemodialysis, a zinc deficiency is found in 40 to 78% of cases. Zinc is a cofactor of more than 70 enzymes. In this observational cohort, the study team seeks to understand the impact of HD and HDF on the serum concentrations of heavy metals and also oligometals, by studying their concentrations in the dialysate during dialysis sessions by inductive coupled plasma mass-spectrometry (ICP-MS).

Description:

Primary objective: Evaluate the trace element concentration (heavy metals Cd and Pb and oligometals: Fe, Zn, Cu, Mn and also Se) in the dialysate before and during dialysis session. By studying the variation in concentration between the initial concentration of trace element in the dialysis fluid and the final concentration after membrane in the dialysate (waste pipe). Method : Prospective study, in dialysis population, inclusion period will be from September 1, 2021 to January 31, 2022, in Ambroise Paré hospital, Paris, France. Duration of follow-up will be 1 day. Dialysate samples will be taken in the venous injection site before connecting the patient, at 0 and 10 minutes after disinfection. After connecting the patients, post-membrane dialysis sample (waste pipe) will be taken at 30, 60, 120 and 180minutes. Trace element dosage will be done by ICP-MS.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18;
• End-stage chronic renal failure in chronic dialysis;
• Duration of dialysis session =3h;
• Vascular approach: arteriovenous fistula;
• Affiliation to a social security scheme or entitled.

Exclusion Criteria:

• Opposition to participate to the study;
• Daily dialysis;
• Duration of dialysis session < 3h and > 8h;
• Vascular approach: venous catheter; Weekly dialysis session =3; Patient under french AME health system.

Related Conditions & MeSH terms

• Dialysis

Locations

Country	Name	City	State
France	Nephrology Department and Dialysis Unit	Boulogne-Billancourt

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	laboratoire ILM - Université Lyon 1 CNRS, UMR 5306 UCBL, MEXBrain 13 avenue Albert Einstein 69100 Villeurbanne

Country where clinical trial is conducted

France, 

References & Publications (9)

Larsson SC, Wolk A. Urinary cadmium and mortality from all causes, cancer and cardiovascular disease in the general population: systematic review and meta-analysis of cohort studies. Int J Epidemiol. 2016 Jun;45(3):782-91. doi: 10.1093/ije/dyv086. Epub 2015 May 20. Review. — View Citation

Lee CC, Weng CH, Huang WH, Yen TH, Lin JL, Lin-Tan DT, Chen KH, Hsu CW. Association Between Blood Cadmium Levels and Mortality in Peritoneal Dialysis. Medicine (Baltimore). 2016 May;95(19):e3717. doi: 10.1097/MD.0000000000003717. — View Citation

Messner B, Knoflach M, Seubert A, Ritsch A, Pfaller K, Henderson B, Shen YH, Zeller I, Willeit J, Laufer G, Wick G, Kiechl S, Bernhard D. Cadmium is a novel and independent risk factor for early atherosclerosis mechanisms and in vivo relevance. Arterioscler Thromb Vasc Biol. 2009 Sep;29(9):1392-8. doi: 10.1161/ATVBAHA.109.190082. Epub 2009 Jun 25. — View Citation

Orr SE, Bridges CC. Chronic Kidney Disease and Exposure to Nephrotoxic Metals. Int J Mol Sci. 2017 May 12;18(5). pii: E1039. doi: 10.3390/ijms18051039. Review. — View Citation

Prodanchuk M, Makarov O, Pisarev E, Sheiman B, Kulyzkiy M. Disturbances of trace element metabolism in ESRD patients receiving hemodialysis and hemodiafiltration. Cent European J Urol. 2014;66(4):472-6. doi: 10.5173/ceju.2013.04.art23. Epub 2014 Jan 27. — View Citation

Roozbeh J, Sharifian M, Sagheb MM, Shabani S, Hamidian Jahromi A, Afshariani R, Pakfetrat M, Salehi O. Comment on: does zinc supplementation affect inflammatory markers in hemodialysis patients? Ren Fail. 2011;33(4):466-7. doi: 10.3109/0886022X.2011.568144. — View Citation

Satarug S, C Gobe G, A Vesey D, Phelps KR. Cadmium and Lead Exposure, Nephrotoxicity, and Mortality. Toxics. 2020 Oct 13;8(4). pii: E86. doi: 10.3390/toxics8040086. Review. — View Citation

Sotomayor CG, Groothof D, Vodegel JJ, Eisenga MF, Knobbe TJ, IJmker J, Lammerts RGM, de Borst MH, Berger SP, Nolte IM, Rodrigo R, Slart RHJA, Navis GJ, Touw DJ, Bakker SJL. Plasma cadmium is associated with increased risk of long-term kidney graft failure. Kidney Int. 2021 May;99(5):1213-1224. doi: 10.1016/j.kint.2020.08.027. Epub 2020 Sep 14. — View Citation

Tonelli M, Wiebe N, Bello A, Field CJ, Gill JS, Hemmelgarn BR, Holmes DT, Jindal K, Klarenbach SW, Manns BJ, Thadhani R, Kinniburgh D; Alberta Kidney Disease Network. Concentrations of Trace Elements in Hemodialysis Patients: A Prospective Cohort Study. Am J Kidney Dis. 2017 Nov;70(5):696-704. doi: 10.1053/j.ajkd.2017.06.029. Epub 2017 Aug 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trace elements concentration	Trace elements concentration in the dialysate during dialysis sessions by inductive coupled plasma mass-spectrometry (ICP-MS).	5 months